efficacy and safety of glucosamine sulfate and chondroitin sulfate combination in treatment of knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: the purpose of this study is to determine whether 500 mg glucosamine sulfate / 400 mg chondroitin sulfate capsules and 1500 mg glucosamine sulfate / 1200 mg chondroitin sulfate sachet is effective and safe compared cosamin ds ® capsule in treatment of knee osteoarthritis.

the groups receive treatment for 16 weeks. the study is realized in 16 sites in brazil.

Eligibility criteria:
inclusion criteria: * male or female patient, older than 40 years of age, with knee osteoarthritis, based on clinical and radiological criteria (kellgren-lawrence grade 2 - 3), as specified: 1. pain on movement of the affected knee for more than 15 days in the previous month with at least partial relief at rest; 2. presence of osteophytes at least 1 mm in radiological imaging; * knee osteoarthritis symptoms for at least six months prior to randomization. exclusion criteria: * concomitant arthropathy that may confuse or interfere with assessing the efficacy or pain; * patellar disease isolated, with primary symptoms of pain in the anterior knee, in the absence of radiological findings already described; * history of significant injury on collateral ligament, or anterior cruciate, or meniscus of the joint studied, with surgery, or immobilization for at least 3 weeks; * arthroscopy of the affected knee in last 6 months; * serum creatinine ≥ 1.8 mg/dl; * diagnosis of diabetes mellitus; * presence of any serious disease that could compromise the study, at the investigator discretion; * history of adverse event or allergy to acetaminophen, glucosamine sulfate or chondroitin sulfate; * inability to understand and report the study questionnaire and the visual analogic scale; * inability to understand and consent to participate in this clinical study, expressed by signing the informed consent (ic); * woman in pregnancy. * if female of childbearing potential, has a negative urine pregnancy test at visit 0 and do not use, or do not agree to use, for the duration of the study, a medically acceptable form of contraception as determined by the investigator; * alcohol intake ( \> 3 doses/day); * oral or intramuscular corticosteroids four weeks prior to study entry; * intra-articular injections with corticosteroids, into the studied knee, within the past three months; * intra-articular injections in any other joint within the past four weeks; * nsaid users that don´t respect the washout period. low-dose aspirin (325 mg or less, once daily) is allowed for cardio-protective benefit; * intra-articular injections of hyaluronic acid within the past 12 months; * use of topical analgesic in the joint studied or any other oral analgesic (with the exception of acetaminophen and other nsaid) two weeks prior to randomization; * implementation of any other medical treatment for osteoarthritis one month prior to study entry; * participation in last one year of clinical protocols, unless it can be direct benefit to patient; * use of glucosamine and/or chondroitin sulfate three and six months prior the study entry, respectively; * initiation of physical therapy two months prior to the study period; * use of tetracycline and oral anticoagulants; * use of vitamin d in doses in doses above the recommended; * patients in alternative therapies; * allergy to sulfonamides; * presence of psychiatric disorders that could compromise the study.

Keywords: knee osteoarthritis; glucosamine; chondroitin.